A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
- Registration Number
- NCT04592874
- Lead Sponsor
- Alector Inc.
- Brief Summary
A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.
- Detailed Description
This is a phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 administered intravenously in participants with Early Alzheimer's Disease.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 328
- Diagnosis of Early AD including evidence of brain amyloidosis by CSF or PET
- MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.
- Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week
- Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker).
- Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia. - Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.
- Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
- Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.
- History or evidence of clinically significant brain disease other than AD.
- Females who are pregnant or breastfeeding, or planning to conceive within the study period.
- Any experimental vaccine or gene therapy.
- History of unresolved cancer.
- Current use of anticoagulant medications.
- Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.
- Participant is positive for presence of APOE e4/e4 genotype.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AL002 Dose 2 AL002 AL002 every 4 weeks Placebo Placebo Placebo every 4 weeks AL002 Dose 1 AL002 AL002 every 4 weeks AL002 Dose 3 AL002 AL002 every 4 weeks
- Primary Outcome Measures
Name Time Method Disease progression as measured by the CDR-SB Through study completion, up to 48 through 96 weeks
- Secondary Outcome Measures
Name Time Method Change in RBANS score Through study completion, up to 48 through 96 weeks Change in ADAS-Cog13 score Through study completion, up to 48 through 96 weeks Change in ADCS-ADL-MCI score Through study completion, up to 48 through 96 weeks Change in ADCOMS score Through study completion, up to 48 through 96 weeks Evaluation of safety and tolerability of AL002: Incidence of adverse events Through study completion, up to 48 through 96 weeks Incidence of adverse events
Change in MMSE score Through study completion, up to 48 through 96 weeks
Trial Locations
- Locations (87)
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Woodlands Research Network, LLC - ERG
🇺🇸Rogers, Arkansas, United States
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
South Florida Neurology Associates
🇺🇸Boca Raton, Florida, United States
Brain Matters Research - ERG
🇺🇸Delray Beach, Florida, United States
Charter Research
🇺🇸Lady Lake, Florida, United States
ClinCloud, LLC
🇺🇸Maitland, Florida, United States
K2 Medical Research
🇺🇸Maitland, Florida, United States
K2 Winter Garden Ocoee
🇺🇸Ocoee, Florida, United States
Scroll for more (77 remaining)Banner Alzheimer's Institute🇺🇸Phoenix, Arizona, United States